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Lifestyle Modification for Obesity-Related Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415688
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Robert C. Atkins Foundation
  Purpose
Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

Condition Intervention Phase
Type 2 Diabetes Mellitus Overweight Obesity Behavioral: Low carbohydrate, ketogenic diet Behavioral: Low glycemic index, reduced calorie diet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Robert C. Atkins Foundation:

Primary Outcome Measures:
  • Hemoglobin A1c

Secondary Outcome Measures:
  • Body weight
  • Serum lipoproteins

Estimated Enrollment: 90
Study Start Date: July 2004
Estimated Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus for at least one year
  • hgba1c > 6.0
  • BMI from 27-50 kg/m2

Exclusion Criteria:

  • Unstable medical condition
  • Serious medical condition
  • AST or ALT > 100
  • Serum creatinine > 1.5
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415688


Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Robert C. Atkins Foundation
Investigators
Principal Investigator: Eric C Westman, MD MHS Duke University Health System
  More Information

ClinicalTrials.gov Identifier: NCT00415688     History of Changes
Other Study ID Numbers: AF001
First Submitted: December 21, 2006
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
Last Verified: December 2006

Keywords provided by Robert C. Atkins Foundation:
lifestyle modification
weight loss
hyperglycemia
hypoglycemic agents

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms